ICH Q7 Guidelines and Practical Approaches to Manufacturing APIs - Webinar by GlobalCompliancePanel

Active Pharmaceutical Ingredient Good Manufacturing Practices (API GMP) are established and defined by the ICH Q7 Guidance. The international supply chain associated with API manufacturing was one of the greatest drivers for the development and international adoption of these expectations by regulators world-wide. The growth in the number of FDA inspections of API producers outside of the USA also played a major role in motivating international interest in the development of a "universal" API GMP.

ICH Q7A Guidelines ( later renamed by ICH as Q7 ) and practical approaches will be examined during this program. All the sections contained within the issued and internationally adopted Guidance will be surveyed and discussed, as only it can be by this actual author of the approved guidance. There are many consultants and "experts" that teach this subject, but almost none have first-hand knowledge of its development.

Some of the behind the scenes background will be discussed so that participants will be able to better understand the true intent of the expert work group's negotiations. What are some key differences from Drug Product GMP and why were these differences established in Q7?